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NCT04488302 Clinical Trial

Ultrasonography and Cone-Beam Computed Tomography for Peri-implant Tissue Evaluation

Ultrasonography Clinical Trial

Official title:
A Retrospective Study on Use of Ultrasonography and Cone-Beam Computed Tomography for Evaluating Peri-implant Tissue

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04488302
Other study ID # HUM00179671
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date July 7, 2020

Study information
Verified date July 2020
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objectives: Although cone‐beam computed tomography (CBCT) is becoming a standard of care in implant therapy, concerns have been raised recently about its limitation in imaging peri-implant tissues due to artifacts. The aim of present study was to demonstrate the complementary role of ultrasound (US), for a comprehensive examination of peri-implant tissues in live humans. Material and Methods: Patients with > 1 implant, a CBCT scan, an US scan, and clinical photographs taken during the open-bone surgery were included. The crestal bone thickness (CBT) and facial bone level (FBL) were measured on both modalities, and direct FBL measurements were also made on clinical images. The correlation plots were made to evaluate the measurement agreements between the 3 methods.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date July 7, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- the patients had to have = 1 implant with a CBCT scan, US scan, and clinical photographs taken during the surgery, e.g. a revision/explantation surgery due to peri-implantitis or a 2nd stage uncover surgery.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)
Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Crestal bone thickness facial bone thickness measured at 1 mm apical to bone crest up to 100 months after implant surgery.
Secondary Facial bone height facial bone height measured from implant platform up to 100 months after implant surgery.
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